A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer

Phase 1

Recruiting

• Conditions: Advanced Prostate Cancer; Metastatic Prostate Cancer
• Interventions: Drug: RO7656594

• Registration Number: NCT05800665
• Lead Sponsor: Genentech, Inc.

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in participants with advanced or metastatic prostate cancer. It will also identify recommended doses and regimens for RO7656594 for subsequent studies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-03-24
• Study First Posted: 2023-04-05
• Study Start: 2023-05-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-07-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 160

Inclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
2. Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.
3. Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
4. Prior therapy with a taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen, unless otherwise specified.
5. For participants with a known pathogenic breast cancer gene 1 (BRCA1) or BRCA2 mutation: prior therapy with a poly (adenosine diphosphate (ADP)-ribose) polymerase (PARP) inhibitor, or are considered ineligible for treatment with a PARP inhibitor, if such therapy is approved and available.

Key

Exclusion Criteria

1. Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives (whichever is longer, not to exceed 28 days) prior to the first study treatment.
2. Treatment with any investigational agent within 28 days prior to the first study treatment.
3. Treatment with any previous AR protein degrader.
4. Untreated central nervous system (CNS) metastases or leptomeningeal disease.

Note: Other protocol specified inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Stage 1: Dose Escalation	RO7656594	Participants will receive RO7656594 administered at a specified dose on specific days in each 28-day cycle. The dose will be increased in successive cohorts until a study-specific threshold is reached.
Stage 2: Expansion	RO7656594	Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)	Days 1-28 of Cycle 1
Percentage of Participants with Adverse Events	From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)

Secondary Outcome Measures

Name	Time	Method
Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594	From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Plasma Concentration of RO7656594	Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)	The pharmacokinetics (PK) of RO7656594 will be evaluated in plasma.
Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594	From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)

Trial Locations

Locations (25)

Tennessee Oncology - Nashville; 🇺🇸 Nashville, Tennessee, United States

HonorHealth; 🇺🇸 Scottsdale, Arizona, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Sarah Cannon Research Institute @ Florida Cancer; 🇺🇸 Orlando, Florida, United States

University of Illinois Hospital & Health Sciences System; 🇺🇸 Chicago, Illinois, United States

St Vincent's Hospital Sydney; 🇦🇺 Darlinghurst, New South Wales, Australia

Monash Health Monash Medical Centre; 🇦🇺 Clayton, Victoria, Australia

Austin Hospital; 🇦🇺 Heidelberg, Victoria, Australia

Macquarie University Hospital; 🇦🇺 New South Wales, Australia

British Columbia Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre Léon Bérard; 🇫🇷 Lyon, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital Yonsei University Health System - PPDS; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center - PPDS; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center - PPDS; 🇰🇷 Seoul, Korea, Republic of

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario Vall d'Hebron - PPDS; 🇪🇸 Barcelona, Spain

Clinica Universidad de Navarra-Madrid; 🇪🇸 Madrid, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Cambridge Clinical Research Centre; 🇬🇧 Cambridge, United Kingdom

Leicester Royal Infirmary; 🇬🇧 Leicester, United Kingdom

The Christie; 🇬🇧 Manchester, United Kingdom

Royal Marsden Hospital - Surrey; 🇬🇧 Sutton, United Kingdom